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Completed Phase 3 Interventional Results available

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

ClinicalTrials.gov ID: NCT00709852

Public ClinicalTrials.gov record NCT00709852. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 6:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-blind, Crossover, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Study identification

NCT ID
NCT00709852
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
402 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2008 (Type not available)
Primary completion
Apr 2009 (Actual)
Completion
Apr 2009 (Actual)
Last update posted
Dec 30, 2014

2008 – 2009

United States locations

U.S. sites
24
U.S. states
17
U.S. cities
23
Facility City State ZIP Site status
West Alabama Research, Inc. Birmingham Alabama 35209 —
Achieve Clinical Research, LLC Tuscaloosa Alabama 35406 —
Los Gatos MRI Los Gatos California 95032 —
Hoag Memorial Hospital Presbyterian Newport Beach California 92658-6100 —
Redwood Regional Medical Group, Inc. Santa Rosa California 95403 —
University of Florida - Jacksonville Jacksonville Florida 32209 —
NorthShore University HealthSystem-Evanston Hospital Evanston Illinois 60201 —
Atchison Hospital Atchison Kansas 66002 —
University of Maryland Hospital System Baltimore Maryland 21201 —
Johns Hopkins Hospital/Health System Baltimore Maryland 21287 —
Shields MRI - Brockton Brockton Massachusetts 02301 —
VA Boston Healthcare System-West Roxbury Division West Roxbury Massachusetts 02132 —
Washington University School of Medicine St Louis Missouri 63110 —
University of New Mexico School of Medicine Albuquerque New Mexico 87131 —
Kingston Neurological Associates, PC Kingston New York 12401 —
NYU Hospital for Joint Diseases New York New York 10003 —
Duke University Medical Center Durham North Carolina 27707 —
The Cleveland Clinic Cleveland Ohio 44195 —
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Rhode Island Hospital Providence Rhode Island 02903 —
Medical University of South Carolina Charleston South Carolina 29425 —
University of Washington Medical Center Seattle Washington 98195 —
Aurora Saint Luke's Medical Center Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00709852, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 30, 2014 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00709852 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →